side effects of vancomycin

Side Effects of Vancomycin - for the Consumer

Vancomycin

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with Vancomycin. Seek medical attention right away if any of these SEVERE side effects occur when using Vancomycin:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; chest pain; decrease in the frequency of urination or in the amount of urine; fever, chills, or sore throat; flushing; irritation, pain, or swelling at the injection site; numbness of an arm or leg; red, swollen, or blistered skin; ringing in the ears or sudden loss of hearing; severe diarrhea; severe stomach pain or cramps; sudden leg pain; sudden severe dizziness, nausea, headache, or vomiting; sudden shortness of breath; unusual bruising or bleeding; wheezing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Vancomycin Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with Vancomycin Capsules.Seek medical attention right away if any of these SEVERE side effects occur when using Vancomycin Capsules:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; decreased urination; fever, chills, or sore throat; flushing; red, swollen, or blistered skin; ringing in the ears or hearing loss; unusual bruising or bleeding; wheezing.


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Side Effects by Body System - for Healthcare Professionals

Renal

Renal side effects have included nephrotoxicity, which has been reported in approximately 5% of patients treated with vancomycin and characterized by increased serum creatinine and BUN concentrations. Rare cases of renal failure, interstitial nephritis, and tubulointerstitial nephritis have been reported. Abnormal renal function has also been reported. The risk of nephrotoxicity has been associated with vancomycin trough levels exceeding 10 mcg/mL.

Nephrotoxicity occurred more frequently with an older, previously marketed formulation of vancomycin. The potential for nephrotoxicity appears to be much lower with the current formulation.

Unusual cases of acute interstitial nephritis have been reported, often associated with rash, eosinophilia, and fever. Acute tubulointerstitial nephritis associated with fatal toxic epidermal necrolysis has also been reported.

Nervous system

Nervous system side effects have included ototoxicity presented as tinnitus or sensorineural hearing loss in association with elevated vancomycin serum concentrations. The hearing loss may be irreversible. Lethargy, headache, dizziness, orthostatic syncope, confusion, and at least one case of neuralgic amyotrophy have been reported. A case of mononeuritis multiplex associated with vancomycin therapy has been reported.

Ototoxicity occurred more frequently with an older, previously marketed formulation of vancomycin. The potential for ototoxicity appears to be much lower with the current formulation.

Severe, irreversible, bilateral sensorineural hearing loss was reported in a 63-year-old male following administration of two 5 mg intrathecal doses of vancomycin in addition to intravenous vancomycin. The patient also experienced headaches, dizziness, orthostatic syncope, and lethargy.

Hematologic

Vancomycin may induce antineutrophilic antibodies. A 48-year-old male developed neutropenia and positive antineutrophilic antibodies after 16 days of vancomycin. His WBC decreased to 600 cells/mm3 but recovered after discontinuation of vancomycin and initiation of granulocyte-colony stimulating factor.

Thrombocytopenia with a positive rechallenge occurred in a 58-year-old male treated for chronic osteomyelitis due to methicillin-resistant Staphylococcus aureus. Vancomycin was initiated at 1 g intravenously every 12 hours and titrated to 1.75 g intravenously every 24 hours by hospital day 9. Platelet count fell from 397,000/mm3 two days before initiation of vancomycin to 22,000/mm3 after 9 days of therapy (hospital day 14). Vancomycin was discontinued and platelets increased to 310,000/mm3 by day 19. Rechallenge with vancomycin on day 22 resulted in a prompt decrease in platelet count to 77,000/mm3 after just 2 days. Platelet count returned to normal a couple days after discontinuation of vancomycin. The patient was subsequently treated with surgery, followed by trimethoprim/sulfamethoxazole and eventually discharged. The mechanism of vancomycin-induced thrombocytopenia was thought to be immune-mediated rather than via a direct toxic effect. Other concurrent medications were ruled out as causative agents.

There were 119 spontaneous reports of thrombocytopenia possibly associated with vancomycin submitted to the manufacturer between 1983 and 1997. In one study (n=285), thrombocytopenia (platelets less than 150 x 10(9)/L) occurred in 7.7% of patients and severe thrombocytopenia (platelets less than 50 x 10(9)/L) occurred in 0.3% receiving vancomycin for more than 5 days.

Hematologic side effects have included reversible neutropenia (2% to 3%) and rare cases of thrombocytopenia, anemia, and agranulocytosis. Leukopenia has also been reported.

Gastrointestinal

Gastrointestinal side effects have included nausea and rare cases of diarrhea, peritonitis, and pseudomembranous colitis.

Rare cases of peritonitis associated with intraperitoneal vancomycin therapy have been reported, but may have been due to chemical impurities in the drug formulation used.

Intraperitoneal administration of vancomycin to patients on continuous ambulatory peritoneal dialysis has been associated with chemical peritonitis, characterized by cloudy dialysate with or without abdominal pain or fever. It is reversible upon discontinuation of intraperitoneal vancomycin.

Other

Other side effects have included drug-induced fever, chills, and red man syndrome.

Infusion of vancomycin over less than 60 minutes has been associated with an increased incidence of red man syndrome. Slowing the infusion rate has generally

decreased or eliminated the syndrome, and pretreatment with antihistamines has increased patient tolerance. Symptoms similar to those of the IV-induced syndrome have also occurred during oral vancomycin therapy. Red man syndrome is caused by a nonspecific release of histamine rather than an allergic reaction.

Local

Local side effects generally have been associated with extravasation of intravenously administered vancomycin and have included pain, tenderness, and necrosis. Thrombophlebitis and nonbullous vancomycin-induced skin necrosis have been reported.

Cardiovascular

Cardiovascular side effects have included phlebitis and vasculitis. Rare cases of dose-dependent hypotension, lupus-like vasculitis, and a leukocytoclastic vasculitis have been reported. A case of cardiac arrest associated with rapid infusion of vancomycin therapy (1 gram intravenously given over 2 minutes) has been reported.

Musculoskeletal

Musculoskeletal side effects have included severe chest, shoulder, and low back pains during intravenous administration of vancomycin in patients undergoing peritoneal dialysis.

Hypersensitivity

A 74-year-old male developed an erythematous rash after 4 days of treatment with vancomycin, piperacillin, tazobactam, and ciprofloxacin. The rash progressed to bullae and skin sloughing that involved 90% of his body, including the oral mucosa, palms, soles, genitals, and conjunctiva, and he became septicemic and died 22 days after onset. Skin biopsies and direct immunofluorescence were consistent with a diagnosis of linear IgA bullous dermatosis.

Six of twenty reported cases of vancomycin-associated linear IgA bullous dermatosis have involved the mucosa and two have involved the conjunctiva.

Hypersensitivity side effects have included erythema multiforme, exfoliative dermatitis, linear IgA bullous dermatosis, Stevens-Johnson syndrome, and anaphylaxis. At least one case of acute tubulointerstitial nephritis associated with fatal toxic epidermal necrolysis has been reported. Drug rash with eosinophilia and systemic symptoms (DRESS syndrome) has been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included rash, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and bullous skin disease. Fatalities have been reported.

Hepatic

Hepatic side effects have included elevated aspartate transaminase (AST) and alanine transaminase (ALT) with oral vancomycin in at least one case report. Abnormal liver function has been reported during intravenous administration.

Respiratory

Respiratory side effects have included at least one case of interstitial pneumonia.

Tigecycline

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Tigecycline:

Diarrhea; dizziness; increased sweating; nausea; pain, swelling, or redness at the injection site; stomach upset; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Tigecycline:Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; fast or slow heartbeat; fever, chills, or sore throat; sensitivity to light; severe headaches; severe or persistent diarrhea; severe or persistent nausea and vomiting; stomach or back pain with or without nausea or vomiting; swollen, tender stomach; symptoms of liver damage (eg, yellowing of the skin or eyes, pale stools, dark urine, loss of appetite); unusual vaginal itching or discharge; vision changes.


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General

In clinical trials, 2514 patients were treated with tigecycline. In comparative trials, serious side effects related to infection were reported more often in patients treated with tigecycline (7%) versus comparators (6%), with sepsis/septic shock reported in 2% and 1% of patients treated with tigecycline and comparator drugs, respectively. The most common side effects were nausea and vomiting which usually occurred within the first 2 days of treatment. Tigecycline was discontinued due to side effects in 7% of patients (compared to 6% for all comparators). Discontinuation was most often due to nausea (1%) and vomiting (1%) in tigecycline-treated patients and nausea (less than 1%) in comparator-treated patients.

In all 13 Phase 3 and 4 trials that included a comparator, death occurred in 4% and 3% of patients receiving tigecycline and comparator drugs, respectively. The cause of this

imbalance has not been determined. In general, deaths resulted from worsening infection, complications of infection, or underlying comorbidities.

Gastrointestinal

The majority of cases of nausea and vomiting were mild to moderate in severity.

Gastrointestinal side effects have included nausea (up to 35%), vomiting (up to 20%), diarrhea (12%), dyspepsia (2%), anorexia (less than 2%), abnormal stools (less than 2%), taste perversion (less than 2%), Clostridium difficile associated diarrhea, pancreatitis, acute pancreatitis (including fatal cases), constipation, and dry mouth. Acute pancreatitis has also been reported during postmarketing experience.

Other

Other side effects have included infection (8%), abdominal pain (6%), abscess (3%), asthenia (3%), sepsis/septic shock (up to 2%), chills (less than 2%), back pain, fever, pain, local reaction to procedure, peripheral edema, and wound infections.

Nervous system

Nervous system side effects have included headache (6%), dizziness (3%), insomnia, and somnolence.

Metabolic

Metabolic side effects have included hypoproteinemia (5%), increased alkaline phosphatase (4%), abnormal healing (4%), increased amylase (3%), hypocalcemia (less than 2%), hypoglycemia (less than 2%), hyponatremia (less than 2%), hyperglycemia, hypokalemia, and increased lactic dehydrogenase.

Hepatic

Hepatic side effects have included increased SGPT (5%), increased SGOT (4%), bilirubinemia (2%), jaundice (less than 2%), hyperbilirubinemia, and increased liver enzymes. Isolated cases of significant hepatic dysfunction and hepatic failure have been reported. Hepatic cholestasis and jaundice have been reported during postmarketing experience.

Hematologic

Hematologic side effects have included anemia (4%), thrombocythemia, and leukocytosis. Prolonged activated partial thromboplastin time (aPTT), prolonged prothrombin time (PT), eosinophilia, increased international normalized ratio (INR), and thrombocytopenia have been reported in less than 2% of patients.

Cardiovascular

Cardiovascular side effects have included phlebitis (3%), thrombophlebitis (less than 2%), hypertension, hypotension, bradycardia, tachycardia, and vasodilatation.

Renal

Renal side effects have included increased BUN (3%) and increased creatinine (less than 2%).

Dermatologic

Dermatologic side effects have included rash (3%), pruritus (less than 2%), and sweating. Diffuse cutaneous hyperpigmentation has also been reported.

Hypersensitivity

Hypersensitivity side effects have included allergic reaction (less than 2%). Anaphylaxis/anaphylactoid reactions have been reported during postmarketing experience.

Local

Local side effects have included injection site pain, injection site inflammation, injection site reaction, injection site phlebitis, and injection site edema in less than 2% of patients.

Genitourinary

Genitourinary side effects have included vaginal moniliasis, vaginitis, and leukorrhea in less than 2% of patients.

Respiratory

Respiratory system side effects have included increased cough, dyspnea, and pulmonary changes.

Side Effects of Linezolid - for the Consumer

Linezolid

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Linezolid:

Bad taste in mouth; constipation; diarrhea; dizziness; headache; nausea; trouble sleeping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Linezolid:Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); agitation; bloody stools; bloody vomit; chills, sore throat, or fever; confusion; exaggerated reflexes; excitation; fast heartbeat; loss of coordination; mental or mood changes; muscle spasms; prolonged or repeated nausea or vomiting; red, swollen, peeling, or blistered skin; seizures; severe or continuing diarrhea; stomach pain/cramps; sweating; swelling of the hands or feet; tingling or numbness of the hands or feet; unusual bleeding or bruising; unusual tiredness or weakness; vaginal irritation or unusual discharge; vision changes (including decreased or blurred vision, changes in color vision, loss of vision); white patches in the mouth.


Linezolid Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Linezolid Suspension:


Seek medical attention right away if any of these SEVERE side effects occur when using Linezolid Suspension:Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); agitation; bloody stools; bloody vomit; chills, fever, or sore throat; confusion; exaggerated reflexes; excitation; fast heartbeat; loss of coordination; mental or mood changes; muscle spasms; prolonged or repeated nausea or vomiting; red, swollen, peeling, or blistered skin; seizures; severe or continuing diarrhea; stomach pain/cramps; sweating; swelling of the hands or feet; tingling or numbness of the hands or feet; unusual bleeding or bruising; unusual tiredness or weakness; vaginal irritation or unusual discharge; vision changes; white patches in the mouth.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about

side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects athttp://www.fda.gov/medwatch .

Linezolid Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Linezolid Tablets:


Seek medical attention right away if any of these SEVERE side effects occur when using Linezolid Tablets:Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); agitation; bloody stools; bloody vomit; chills, fever, or sore throat; confusion; exaggerated reflexes; excitation; fast heartbeat; loss of coordination; mental or mood changes; muscle spasms; prolonged or repeated nausea or vomiting; red, swollen, peeling, or blistered skin; seizures; severe or continuing diarrhea; stomach pain/cramps; sweating; swelling of the hands or feet; tingling or numbness of the hands or feet; unusual bleeding or bruising; unusual tiredness or weakness; vaginal irritation or unusual discharge; vision changes (including decreased or blurred vision, changes in color vision, loss of vision); white patches in the mouth.


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General

Linezolid was evaluated in 2046 patients with 85% of adverse events reported as mild to moderate. The most common side effects reported were diarrhea, headache, and nausea.

Gastrointestinal

In cases with known outcome, tooth discoloration was removable with professional dental cleaning (manual descaling).

A 60-year-old man with spondylodiscitis developed a fatal case of Clostridium difficile colitis after a long-term course of linezolid therapy.

Gastrointestinal side effects have included diarrhea (up to 11%), nausea (up to 9.6%), vomiting (3.7%), constipation (2.2%), taste alteration (up to 1.8%), tongue discoloration (up to 1.1%), oral moniliasis (up to 1.1%), dyspepsia, localized abdominal pain, lingua villosa nigra, and pseudomembranous colitis. Superficial tooth discoloration and tongue discoloration have been reported during postmarketing experience.

Hematologic

Hematologic side effects have included decreased hemoglobin (up to 7.1%), platelet count (up to 3%), white blood cells (up to 2.2%), and neutrophils (up to 1.1%). Phase 3 studies have shown a 2.4% incidence of low platelet counts (less than 75% of lower limit of normal) in relation to 1.5% for comparator drugs. Four of these patients required platelet transfusions. Red cell hypoplasia (0.5%) and decreased hemoglobin and hematocrit (4.7%) have also been reported. Myelosuppression (including anemia, leukopenia, pancytopenia, and thrombocytopenia) has been reported during postmarketing experience.

Complete blood counts should be monitored weekly in patients who receive linezolid, particularly in those who receive linezolid for longer than two weeks, those with preexisting myelosuppression, those receiving concomitant drugs that produce bone marrow suppression, or those with chronic infection who have received previous or concomitant antibiotic therapy. Discontinuation of therapy should be considered in patients who develop or have worsening myelosuppression.

In one case, linezolid was successfully restarted at a reduced dose after resolution of myelotoxicity.

Thrombocytopenia (platelets less than 100,000/mm3) has been reported in 32% of patients (n=19) receiving linezolid for more than 10 days. In another study (n=295), thrombocytopenia (platelets less than150 x 10(9)/L) occurred in 6.4% of patients and severe thrombocytopenia (platelets less than 50 x 10(9)/L) occurred in 0.3% receiving linezolid for more than 5 days. It has been suggested that the mechanism of linezolid-associated thrombocytopenia is immune-mediated.

In a study of patients with linezolid-associated thrombocytopenia, the administration of vitamin B6 was shown to help reverse the incidence of thrombocytopenia. Vitamin B6 was most effective when it was administered after linezolid treatment was held. Once hematologic levels were returned to baseline, concomitant administration of linezolid and

vitamin B6 resulted in stable hemoglobin levels for the remainder of linezolid therapy.

Another study compared linezolid plus 50 mg vitamin B6 per day (n=31) with linezolid alone (n=62) administered to patients with cancer. This study concluded vitamin B6 was not beneficial in the prevention of leukopenia or thrombocytopenia, but found a possible trend towards the prevention of anemia.

Nervous system

Nervous system side effects have included headache (up to 11.3%), insomnia (2.5%), dizziness (up to 2%), drowsiness, confusion, and seizure. At least one case of Bell's palsy has been reported. Serotonin syndrome (in patients receiving concomitant serotonergic agents), convulsions, peripheral neuropathy, and optic neuropathy (sometimes progressing to loss of vision) have been reported during postmarketing experience.

Several cases of peripheral and/or optic neuropathy have been reported, mainly in patients where the duration of therapy was longer than 28 days. For example, irreversible sensory loss and peripheral neuropathy have been reported in a patient after 6 months of linezolid therapy for actinomycosis. The time from the onset of linezolid treatment to the first sign of peripheral neuropathy averaged 4 months (range 10 days to 6 months) in 10 patients with only peripheral neuropathy. In all patients with peripheral neuropathy (n=16), complete recovery was not observed following linezolid discontinuation.

At least 15 instances of serotonin syndrome have been reported in patients receiving linezolid during treatment with citalopram, sertraline, venlafaxine, fluoxetine, or paroxetine. Other concurrent drugs and/or comorbidities may have contributed to the patients developing serotonin syndrome. The time from the onset of linezolid treatment to the first sign of serotonin syndrome averaged 4 days (range 1 to 20 days) and from the first sign to stopping linezolid ranged from 1 to 16 days. The symptoms resolved within 1 to 9 days in 14 patients while one patient died suddenly. Three patients died. The first patient developed symptoms 3 weeks after concurrent treatment with linezolid and citalopram. The patient developed severe lactic acidosis followed by myocardial infarction, and after 3 further episodes of cardiac arrest, the patient died. The second patient stopped sertraline on day 1 and developed symptoms on day 9 of linezolid treatment. The patient had cardiopulmonary arrest, then anoxic brain injury, hypertension, tachycardia, and diarrhea, and died in 2 weeks. This patient had a similar incident 6 weeks earlier when linezolid and sertraline were administered. The third patient, who was receiving citalopram, developed symptoms on day 2 of linezolid treatment and died with cerebral hemorrhage one month following the start of serotonin syndrome despite stopping linezolid.

A 49-year-old male with multiple comorbidities was started on oral linezolid 600 mg twice

a day following intravenous vancomycin for the treatment of osteomyelitis. On day 21 of linezolid treatment, the patient reported a strange sensation in his mouth without any pain, sores, or blisters. On day 22, the patient's left eye began to tear inexplicably and he was not able to drink properly. On day 23, left facial frowning and excessive tearing of his left eye was observed on examination. Left-sided facial weakness involving the upper and lower facial muscles was discovered on physical examination. Bell's palsy was diagnosed. Linezolid was discontinued and by day 90, the Bell's palsy completely resolved. Five months later, the patient was restarted on oral linezolid 600 mg twice a day following intravenous vancomycin treatment. On day 21 of linezolid treatment, the patient again developed upper and lower facial muscle weakness on his left side. The linezolid was discontinued and by day 35, the Bell's palsy had practically resolved. Four months following his second episode, the patient had no remaining symptoms.

Metabolic

Metabolic side effects have included lactic acidosis, hyperlactatemia, metabolic acidosis, hyponatremia, and hypokalemia. Elevated lipase (up to 4.3%), alkaline phosphatase (up to 3.5%), amylase (up to 2.4%), LDH (up to 1.8%), and creatine phosphokinase (0.5%) have been reported. Lactic acidosis has also been reported during postmarketing experience.

At least 7 instances of lactic acidosis have been reported following linezolid therapy. The time from the onset of linezolid treatment to the first sign of lactic acidosis ranged from 1 to 16 weeks. Linezolid was stopped within 4 days of identifying lactic acidosis. Two of the 7 patients died despite stopping linezolid. The lactate levels normalized in the 5 surviving patients after stopping linezolid, but one of the patients had sequelae of blindness and disorientation.

Ocular

Several cases of peripheral and/or optic neuropathy have been reported. The time from the onset of linezolid treatment to the first sign of optic neuropathy averaged 10 months (range 1 to 48 months) in 6 patients with only optic neuropathy. The time to discontinuation of linezolid due to optic neuropathy averaged 11 months (range 1 to 56 months) following therapy initiation. Linezolid was stopped in 12 cases following the development of optic neuropathy; improvement or complete recovery was observed in all cases.

Ocular side effects have included optic neuropathy, sometimes in conjunction with peripheral neuropathy after long-term treatment (6 to 10 months). Partially irreversible bilateral optic neuritis has been reported in a patient after 41 weeks of linezolid therapy. Optic neuropathy (sometimes progressing to loss of vision) has also been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included rash (2%), pruritus, and mild alopecia. Bullous skin disorders (such as those described as Stevens-Johnson syndrome) have been reported during postmarketing experience.

Cardiovascular

Cardiovascular side effects have included increased and decreased blood pressure and supraventricular tachycardia (0.5%).

The potential for hypertensive crisis exists when linezolid is taken concurrently with foods high in tyramine due to the monoamine oxidase inhibiting properties of linezolid.

Genitourinary

Genitourinary side effects have included vaginal moniliasis (up to 1.6%).

Hepatic

Hepatic side effects have included abnormal liver function tests (up to 1.3%). Elevated ALT (up to 9.6%), AST (up to 5%), and total bilirubin (up to 0.9%) have been reported.

Renal

Renal side effects have included exacerbation of renal failure (0.5%) and abnormal renal function. Elevated BUN (up to 2.1%) and creatinine (0.2%) have been reported. Acute interstitial nephritis has been reported.

Other

Other side effects have included fever (1.6%) and generalized edema.

Respiratory

Respiratory side effects have included at least one case of interstitial pneumonia.

Hypersensitivity

Hypersensitivity side effects have included anaphylaxis and angioedema during postmarketing experience.

Immunologic

Immunologic side effects have included fungal infection (up to 1.5%). Superinfection may occur in patients due to overgrowth of resistant organisms.

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Side Effects of Rifampin - for the Consumer

Rifampin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Rifampin:

Diarrhea; dizziness; drowsiness; gas; headache; heartburn; menstrual changes; mild upset stomach or cramps.

Seek medical attention right away if any of these SEVERE side effects occur when using Rifampin:Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or dark urine; change in the amount of urine produced; confusion; dark, tarry, or bloody stools; fever, chills, or sore throat; joint pain or swelling; muscle pain or weakness; nausea; pain, swelling, or redness at the injection site; red, swollen, blistered, or peeling skin; severe diarrhea, stomach pain, or cramps; shortness of breath; swelling of the arms, face, or legs; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the eyes or skin); unusual bruising or bleeding; unusual tiredness or weakness; vision changes; vomiting.


Rifampin Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Rifampin Capsules:

Diarrhea; dizziness; drowsiness; gas; headache; heartburn; menstrual changes; mild upset stomach or cramps.

Seek medical attention right away if any of these SEVERE side effects occur when using Rifampin Capsules:

http://www.drugs.com/sfx/linezolid-side-effects.html

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or dark urine; change in the amount of urine produced; confusion; dark, tarry, or bloody stools; fever, chills, or sore throat; joint pain or swelling; muscle pain or weakness; nausea; red, swollen, blistered, or peeling skin; severe diarrhea, stomach pain, or cramps; shortness of breath; swelling of the arms, face, or legs; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the eyes or skin); unusual bruising or bleeding; unusual tiredness or weakness; vision changes; vomiting.


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Gastrointestinal

Gastrointestinal side effects have included nausea and dyspepsia in 2% of patients. Heartburn, anorexia, vomiting, flatulence, cramps and diarrhea have also been observed. Rare cases of pill-induced esophagitis and pseudomembranous colitis have been associated with the use of rifampin.

Hepatic

Hyperbilirubinemia and hepatitis have been reported in up to 3% of patients. Approximately 50% of hepatotoxicity has been observed during the first month of therapy.

If rifampin is essential in the treatment of patients with liver disease, extreme caution and strict medical supervision should be exercised. Baseline liver function tests should be obtained and monitored every two weeks during therapy.

Hepatic side effects have included cases of hepatitis and severe hepatotoxicity with fatal outcome. Fatal cases of hepatotoxicity have been observed in patients with existing liver dysfunction and in patients with normal liver function who are also taking other hepatotoxic drugs. Jaundice, hepatitis, transient abnormalities in liver function tests (e.g., elevations in serum bilirubin, BSP, alkaline phosphatase, serum transaminases), and hyperbilirubinemia have been reported. Baseline and periodic liver function testing are recommended for all patients on long-term rifampin therapy.

Immunologic

The 'flu-like syndrome' generally occurs with intermittent dosing of rifampin, in patients with poor adherence to daily rifampin therapy, and when daily rifampin is resumed after a drug free period.

Immunologic side effects have included flu-like syndrome presenting as fever, malaise, nausea, vomiting, petechiae and myalgias. This syndrome is probably an immune-mediated reaction. Rarely, dyspnea and shock have been associated with once-daily rifampin therapy.

Renal

There have been rare case reports of reversible acute renal failure due to glomerulonephritis and renal epithelial cell injury in patients receiving rifampin. Often in these patients other immune-mediated reactions occur, such as hemolysis and thrombocytopenia. Antibodies to rifampin have been identified in some affected patients. Generally these reactions occur after reintroduction of the drug following a lapse in therapy, although they have also been associated with continuous therapy.

Renal side effects have included elevations in BUN and serum uric acid. Hemoglobinuria, hematuria, interstitial nephritis, acute tubular necrosis, renal insufficiency, and acute renal failure have been reported. These events are generally associated with an immune-mediated reaction which occurs after interruption in rifampin therapy. Standard doses may produce orange-colored urine.

Hematologic

Petechiae associated with thrombocytopenia may occur in 1% of patients who are receiving rifampin. Rifampin antibodies have been demonstrated in some of these patients. Thrombocytopenia is seen most frequently in patients receiving weekly therapy or after a lapse in therapy, but has also been reported during daily therapy. Decreased hemoglobin and transient leukopenia have been reported in patients who had chronic diseases and in whom other medications were given, which made it difficult to definitively determine if these adverse effects were due to rifampin.

A 76-year-old male with a diagnosis of Mycobacterium kansasii pulmonary disease experienced leukocytoclastic vasculitis, thrombocytopenia, and acute renal failure coincident with rifampin therapy. He was admitted to the hospital with a one-week history of fever, dry cough, dyspnea, oliguria, and bilateral edema in lower extremities. He was treated for the Mycobacterium kansasii pulmonary disease with a combined preparation of isoniazid 50 mg, rifampin 250 mg, rifampin 600 mg, and pyrazinamide 1500 mg (Rifater). On the patients admission, laboratory data showed acute renal failure (serum creatinine 9.6 mg/dL, urea 168 mg/dL) and thrombocytopenia (platelets 85 x 10 (3)/

microliter). Other results were WBC count 13,300/ microliter, hemoglobin 13.9 g/dL, and proteinuria, with urine protein 1.5 g/L. Pyrazinamide was discontinued and broad spectrum antimicrobials were introduced. Two weeks after pyrazinamide was discontinued, clinical and analytical parameters normalized. With the goal of treating Mycobacterium kansasii, a controlled trial of rifampin at increasing doses (80 mg the first day, 150 mg the second day, 200 mg the third day) was attempted a week later. The day following reintroduction, a palpable purpura appeared, serum creatinine increased (1.9 mg/dL), and the platelet count dropped. Rifampin was withdrawn on the fourth day; 4 days later, the serum creatinine level returned to within normal limits and skin purpura disappeared. Skin purpura biopsy demonstrated leukocytoclastic vasculitis. Two weeks later, the patient was discharged with normal renal function and platelet count.

Hematologic side effects have included thrombocytopenia, leukopenia, hemolytic anemia, and decreased hemoglobin, in less than 1% of patients. Thrombocytopenia has occurred primarily with high dose intermittent therapy, and after resumption of interrupted therapy. Red cell aplasia, agranulocytosis, methemoglobinemia, and disseminated intravascular coagulation have been reported very rarely. Hemolysis has been described as part of an immune-mediated reaction which generally occurs after interruptions in therapy. At least one case of rifampin-related leukocytoclastic vasculitis, thrombocytopenia, and acute renal failure has been reported.

Dermatologic

Dermatologic side effects have included cutaneous reactions that are mild and self-limiting and usually not associated with a hypersensitivity to rifampin. These reactions generally manifest as itching and flushing with or without rash. Serious dermatologic reactions that resulted from hypersensitivity have been reported rarely.

Nervous system

Nervous system side effects have included headache, paresthesias, and weakness. Other central nervous system side effects reported have included drowsiness, fatigue, ataxia, dizziness, decreased concentration, mental confusion, behavioral changes, muscular weakness, pain, and numbness.

Metabolic

Drug level monitoring may be necessary in patients who remain acid-fast bacilli smear positive after 3 months of directly observed therapy. Dosage may be titrated upwards to keep the rifampin level in the therapeutic range.

Metabolic side effects have included increases in hepatic metabolism of thyroxine (T4) and triiodothyronine (T3). A fall in plasma concentration time curve of rifampin and an

increase in renal clearance due to a decrease in protein-bound drug has been reported in pulmonary tuberculosis patients who are often malnourished.

Cardiovascular

Cardiovascular side effects have been reported rarely. These have included decreased blood pressure when rifampin dosages were administered intermittently.

Hypersensitivity

A 35-year-old male who was diagnosed with pulmonary tuberculosis experienced multiple hypersensitivity reactions coincident with rifampin therapy. After being admitted to the hospital with multiple symptoms of tuberculosis, the patient was prescribed rifampin, isoniazid, pyrazinamide, and ethambutol. Two hours after taking the first pill of rifampin (600 mg), the patient developed anaphylactic shock, liver injury, hemolytic anemia, acute renal failure, and disseminated intravascular coagulation. Direct and indirect antiglobulin (Coombs) tests were positive. RFP-dependent IgG and IgM antibodies with complement fixing capability were observed in the serum. The patient was transferred to the intensive care unit and underwent hemodialysis. Clinical recovery and return of laboratory data to normal levels occurred over a 5-week period. The patient was subsequently given isoniazid, pyrazinamide, ethambutol, ciprofloxacin, and recovered from tuberculosis.

Hypersensitivity side effects have included urticaria, rash, pruritus, pemphigoid reaction, erythema multiforme including Stevens-Johnson syndrome, toxic epidermal necrolysis, vasculitis, eosinophilia, sore mouth, sore tongue, and conjunctivitis. Rarely, anaphylaxis has been reported. At least one case of multiple hypersensitivity reactions including anaphylactic shock, liver injury, hemolytic anemia, acute renal failure, and disseminated intravascular coagulation have also been reported.

Endocrine

Endocrine side effects have included menstrual disturbances and rare reports of adrenal insufficiency in patients with impaired adrenal function.

Musculoskeletal

Musculoskeletal side effects have included myopathy and muscular weakness.

Ocular

Ocular side effects have included visual disturbances. Ocular side effects are generally limited to patients who wear contact lenses. Rifampin can cause a red-brown or orange discoloration of tears which can stain contact lenses.

Psychiatric

Psychiatric side effects have rarely included psychoses.

Respiratory

Respiratory side effects have included shortness of breath and wheezing with the use of intermittent dosage regimens. A 'flu syndrome' may appear if rifampin is taken irregularly or if daily administration is resumed after a drug free interval.

Other

Other side effects have rarely included edema of the face and extremities.

Other

Fatal acute overdoses have been reported with doses ranging from 14 to 60 grams of rifampin. Alcohol or a history of alcohol abuse was involved in some of the fatal and nonfatal cases. The minimum acute lethal or toxic dose is not well established.

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